Clairity
Clairity provides Clairity Breast, an FDA-authorized AI platform that predicts a woman's five-year breast cancer risk directly from a routine screening mammogram. It serves U.S. health systems, academic medical centers, and breast imaging networks via enterprise SaaS, channel integrations, and direct-to-consumer access.
- Company typePrivate
- Founded2020
- HeadquartersAustin, United States
- Headcount11–50
- GTM typeB2B
- OfferingSoftware
What Clairity does
Clairity, Inc., founded in 2020 and headquartered at 361 Newbury Street, Boston, Massachusetts, develops an AI-powered precision health platform that converts routine screening mammograms into a personalized five-year risk score for breast cancer. Its flagship Software as a Medical Device, Clairity Breast (FDA-authorized under the device name Allix5 via De Novo in May 2025), applies proprietary deep-learning and pixel-level radiomics analysis to full-field digital mammograms and directly acquired 2D images from compatible systems such as Hologic Lorad Selenia/Selenia Dimensions. The model was trained on millions of mammograms with five-year outcome data and validated across more than 122,000 mammograms spanning ten U.S. health systems and European screening programs, achieving a clinical accuracy of AUC 0.72 and identifying a 2–4x higher risk in women missed by traditional density-based methods. Clairity Breast is the first AI mammography risk tool incorporated into the NCCN 2026 Clinical Practice Guidelines for Breast Cancer Screening and Diagnosis, with a 1.7% risk threshold and eligibility starting at age 35.
The platform is delivered to U.S. health systems, academic medical centers, and specialty breast imaging networks through an enterprise SaaS / risk-assessment software licensing model (quote-based, multi-year), embedded inside MagView's Luminary Risk workflow software that reaches 2,500+ U.S. imaging facilities, and combined with Myriad Genetics' MyRisk Hereditary Cancer Test via a co-developed AI + genetic risk offering launched in November 2025. Secondary revenue mechanics include a $40–$60 imaging-center add-on and a $199 direct self-pay option for individual risk scores; insurance coverage remains limited. Named deployments include Beth Israel Deaconess Medical Center (first commercial patient February 23, 2026), Emory University, and Invision Sally Jobe, with a state-by-state U.S. rollout underway (Massachusetts launched; Colorado scheduled April 2026). Clairity is led by founder/CEO Dr. Connie Lehman, with Joe Kiani (founder of Masimo) as Chairman, and has raised approximately $50 million in disclosed funding, most recently a $43 million Series B in November 2025 co-led by ACE Global Equity and Santé Ventures with participation from the Breast Cancer Research Foundation.
Clairity firmographics
Firmographics- Name
- Clairity
- Legal name
- Clairity, Inc.
- Website
- https://clairity.com
- Company type
- Private
- Founded year
- 2020
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Clairity provides Clairity Breast, an FDA-authorized AI platform that predicts a woman's five-year breast cancer risk directly from a routine screening mammogram. It serves U.S. health systems, academic medical centers, and breast imaging networks via enterprise SaaS, channel integrations, and direct-to-consumer access.
- Ownership category
- akta.pro rank
Clairity industry classification
Industry- Product category
- Medical Imaging AI Software / Precision Health Diagnostics
- NAICS
- Computer Systems Design and Related Services (54151)
- akta.pro primary industry
- Medical Imaging AI (HDAAAEAH)
- akta.pro secondary industry
- SaMD – Imaging & Signal Analysis (AI/ML) (HLACANAG)
Keywords
Where Clairity is headquartered
LocationHeadquarters
- HQ city
- Austin
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Clairity business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Technology or R&D, Personnel, Marketing or Sales, Operations, Others
Revenue model
- Enterprise SaaS / risk-assessment software licensing to health systems and imaging centers: Recurring software access deployed within clinical imaging workflows (e.g., integration with MagView's Luminary Risk used by 2,500+ U.S. facilities and with Myriad Genetics testing workflows). Billed to healthcare providers per the B2B health system contract model.
- Per-test / per-mammogram patient access fees (self-pay and imaging-center add-on): Some imaging centers offer the AI analysis as an optional add-on for $40–$60; self-pay option priced at $199. Insurance coverage remains limited, indicating near-term revenue from out-of-pocket per-assessment transactions.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Imaging center add-on (optional AI risk assessment at time of screening) |
| Unit Pricing | Pay-as-you-go | Direct self-pay patient pricing |
| Other | Multi-year contract | Enterprise health system pricing (quote-based) |
Go-to-market motion3 records
Distribution channels4 records
Marketing channels6 records
Clairity product offering
Product offeringCore offering
Clairity develops and commercializes Clairity Breast (FDA-authorized under the device name Allix5), a Software as a Medical Device (SaMD) that applies deep learning and computer vision to full-field digital mammograms from Hologic Lorad Selenia / Selenia Dimensions systems to output a five-year probability of a woman developing breast cancer, without relying on family history or genetic inputs. The platform is sold primarily as enterprise SaaS/risk-assessment software licensed to U.S. health systems and imaging centers, integrated with MagView's Luminary Risk workflow and Myriad's MyRisk genetic testing, and is also offered as an imaging-center add-on ($40-$60) or self-pay ($199) for individual risk-score access.
Product overview
Clairity, Inc. offers a single unified product, Clairity Breast (FDA-authorized under the device name Allix5), an AI-powered Software as a Medical Device that analyzes routine screening mammograms to produce a personalized 5-year breast cancer risk score. The platform is extended through a workflow integration with MagView's Luminary Risk software that brings Clairity Breast's risk score together with Myriad Genetics' MyRisk Hereditary Cancer Test (with RiskScore) results, so radiologists can act on combined image-based and genetic risk inside their existing breast imaging workflow.
Differentiator
Problem solved
Functional benefit
Brands
- Clairity Breast: First FDA-authorized AI platform that predicts a woman's five-year future risk of developing breast cancer using only her existing screening mammogram. Authorized under the name Allix5.
Products and services
- Clairity Breast (FDA-authorized device name: Allix5) Clairity Breast is Clairity's flagship Software as a Medical Device (SaMD) that uses deep learning and computer vision to analyze full-field digital mammograms (or directly acquired 2D images from Hologic Lorad Selenia / Selenia Dimensions systems) and output a personalized five-year probability of a woman developing breast cancer, without relying on family history or genetic inputs. It is FDA De Novo-authorized under the device name Allix5, validated across 120,000+ mammograms from ten U.S. health systems and European screening programs (AUC 0.72), and is sold to U.S. health systems, academic medical centers, and specialty breast imaging networks with deployments at Beth Israel Deaconess Medical Center, Emory University, and Invision Sally Jobe.
Quantifiable outcome
- 5.9% breast cancer incidence in AI high-risk women vs 1.3% in average-risk (validation studies)
- +4 more outcomes
Companies that use Clairity
Customer profileNamed customers5 records
Segments3 records
Ideal customer profiles3 records
Clairity technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration3 records
AI capability3 records
Feature4 records
Clairity partnerships and signals
Strategic signalPartnerships
14 partnerships are on record, tiered industry alliance participation, flagship launch site, strategic advisory, flagship commercial integration, flagship distribution channel, founding clinical / data partner, founding research partner, data partner, founding data partner + customer, international data partner, imaging-system compatibility partner and real-world deployment site.
- Patient Safety Movement Foundationindustry alliance participationClairity Inc. signed the Patient Safety Movement Foundation's Open Data Pledge (announced March 30, 2026), joining 90+ organizations committed to making clinical data accessible in secure ways to improve patient safety. The pledge enables appropriate access to data from medical technologies including EHRs, infusion pumps, and physiological monitors, supporting AI-driven predictive algorithms. Joe Kiani (Clairity Chairman) founded the Patient Safety Movement Foundation in 2012.
- Beth Israel Deaconess Medical Center (BIDMC)flagship launch siteFirst medical center in the U.S. to offer Clairity Breast; the first clinical patient received a Clairity Breast cancer risk score on February 23, 2026, marking the clinical debut of the FDA-authorized platform.
- Clairity Strategic Advisory Boardstrategic advisoryStrategic Advisory Board formed December 2, 2025 to support deployment of Clairity's AI-based health prediction tools and the global rollout of its predictive AI technologies at scale. Includes leaders from diagnostics, digital health, and life sciences.
- Myriad Geneticsflagship commercial integrationJointly developed and launched (Nov 25, 2025) the first integrated AI and genetic risk platform for personalized breast health, combining Clairity Breast (image-based AI) with Myriad's MyRisk Hereditary Cancer Test with RiskScore within MagView's Luminary Risk workflow software. Strategic collaboration also covers U.S. integrated breast cancer risk assessment.
- MagViewflagship distribution channelCo-developed and distributed the first integrated AI + genetic risk platform for personalized breast health. MagView's Luminary Risk workflow software is used by more than 2,500 facilities across the United States, providing broad distribution for Clairity Breast alongside Myriad's MyRisk Hereditary Cancer Test.
- Massachusetts General Brigham (MGH) / Massachusetts General Hospitalfounding clinical / data partnerFounding data partner of Clairity's Data Partner Consortium, contributing clinical expertise, patient diversity, and data excellence for AI model development and validation. Founder Dr. Connie Lehman was a Breast Imaging Specialist at MGH (on leave).
- MIT (Massachusetts Institute of Technology)founding research partnerFounding data partner and academic research collaborator. Founder Dr. Lehman has a documented research collaboration with MIT that helped fuel Clairity's founding.
- Stanford Universitydata partnerMember of Clairity's founding Data Partner Consortium, contributing thought leadership, clinical expertise, and patient diversity.
- UC Davisdata partnerMember of Clairity's founding Data Partner Consortium, contributing clinical expertise, patient diversity, and data excellence.
- Emory Universityfounding data partner + customerFounding data partner of Clairity's Data Partner Consortium and a real-world implementation site referenced in the company's careers page.
- RWTH Aachen University (Aachen)international data partnerMember of Clairity's founding Data Partner Consortium, contributing international scale and screening-program data for AI validation.
- MD Anderson Cancer Center (MDA)data partnerMember of Clairity's founding Data Partner Consortium, contributing oncology clinical expertise and patient data.
- Hologic (Lorad Selenia / Selenia Dimensions)imaging-system compatibility partnerClairity Breast analyzes full-field digital mammograms or directly acquired 2D images from Hologic Lorad Selenia and Selenia Dimensions Mammography Systems (does not analyze synthetic 2D images). Implies technical compatibility/validation with Hologic mammography hardware.
- Invision Sally Jobereal-world deployment siteReal-world implementation site for Clairity Breast, referenced on the careers page among centers of excellence alongside Beth Israel Deaconess Medical Center and Emory University.
Scale indicators13 records
Recent moves8 records
Expansion highlights7 records
Clairity competitors and assessment
Company assessmentDirect peers
- iCAD (DeepHealth): AI mammography vendor offering ProFound AI for breast cancer detection and risk; competes with Clairity in image-based breast AI deployed inside radiology workflows at U.S. health systems and imaging centers.
- Volpara Health: Breast health analytics platform focused on breast density, risk modeling, and imaging workflow; targets the same U.S. health system and mammography center customers and overlaps with Clairity on image-based risk and density-driven screening decisions.
- Lunit: Korean AI company with FDA-cleared Lunit INSIGHT MMG for mammography detection and Lunit SCOPE for biomarker prediction; competes with Clairity in image-based breast AI sold to hospitals and screening programs.
- Therapixel: Developer of MammoScreen 2.0, an FDA-cleared AI for mammography triage and decision support; directly competes with Clairity in image-based breast AI used by radiologists at point of screening.
- ScreenPoint Medical: Developer of Transpara, an AI decision-support tool for breast imaging that provides lesion detection and risk scoring; comparable to Clairity as an image-only AI deployed inside mammography workflow.
Broad incumbents
- Hologic: Incumbent mammography hardware vendor whose Lorad Selenia/Selenia Dimensions systems are Clairity's current compatibility partner; also developing its own Genius AI Detection and risk applications, making it both a partner and potential competitor.
- GE HealthCare: Global imaging OEM and healthcare AI provider whose mammography systems and Edison AI platform offer integrated breast imaging AI; comparable as a broad incumbent that can bundle risk-prediction AI with hardware and enterprise contracts.
- Siemens Healthineers: Mammography hardware vendor with AI-augmented breast imaging (e.g., AI-Rad Companion) deployed across large health system installed bases; overlaps with Clairity on image-based risk and screening workflow.
Others
- Myriad Genetics: Strategic commercial partner integrating MyRisk Hereditary Cancer Test with RiskScore alongside Clairity Breast; adjacent rather than directly competitive, but operates in the same women's health risk-assessment workflow and could evolve into a competitor.
Emerging players
- GRAIL: Multi-cancer early detection company (Galleri test) pursuing blood-based cancer risk and screening; comparable as a precision health risk-prediction platform selling into U.S. health systems and competing for the same preventive-screening dollar.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat6 records
Key risks6 records
Key highlights7 records
Customer concentration
Clairity social profiles
Digital presenceClairity compliance and trust
Trust signalCompliance3 records
Clairity financial estimates
Financial estimateRevenue estimate
Valuation estimate
Clairity leadership team
Management profileNumber of profiles
Profiles12 records
Clairity funding detail
Funding detailFunding overview
Funding rounds2 records
Investors3 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Clairity M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Clairity
What does Clairity do?
Clairity develops and commercializes Clairity Breast (FDA-authorized under the device name Allix5), a Software as a Medical Device (SaMD) that applies deep learning and computer vision to full-field digital mammograms from Hologic Lorad Selenia / Selenia Dimensions systems to output a five-year probability of a woman developing breast cancer, without relying on family history or genetic inputs. The platform is sold primarily as enterprise SaaS/risk-assessment software licensed to U.S. health systems and imaging centers, integrated with MagView's Luminary Risk workflow and Myriad's MyRisk genetic testing, and is also offered as an imaging-center add-on ($40-$60) or self-pay ($199) for individual risk-score access.
Is Clairity a public or private company?
Clairity is a private company. It is classified as venture growth investor backed and is currently operating.
When was Clairity founded?
Clairity was founded in 2020. It employs 11 to 50 people.
Where is Clairity based?
Clairity is headquartered in Austin, United States, in the North America region.
How does Clairity make money?
Two revenue lines are on record. Enterprise SaaS / risk-assessment software licensing to health systems and imaging centers are the primary driver. The others are per-test / per-mammogram patient access fees (self-pay and imaging-center add-on).
Who are Clairity's main competitors?
Direct peers on record are iCAD (DeepHealth), Volpara Health, Lunit, Therapixel and ScreenPoint Medical. Broad incumbents are Hologic, GE HealthCare and Siemens Healthineers. Myriad Genetics is listed as an others. GRAIL is listed as an emerging player.
Does Clairity have an API?
No public API is recorded for Clairity.
What industry is Clairity in?
Clairity's product category is Medical Imaging AI Software / Precision Health Diagnostics. Its primary akta.pro industry code is HDAAAEAH, Medical Imaging AI, with a secondary code of HLACANAG, SaMD – Imaging & Signal Analysis (AI/ML). Its NAICS code is 54151.